High potency active pharmaceutical ingredients (HPAPI) are highly effective in small doses, and require sophisticated manufacturing facilities and specialized technical capabilities. These APIs have drastically improved the standards of medical treatment. Advantages of targeted therapy and high revenue returns has boosted research and development in this field. High potency API manufacturing is a challenging task and mainly confined to captive manufacturing. Pharmaceutical companies have only recently started outsourcing HPAPI production to contract manufacturing organization to effectively utilize outside expertise, while managing escalating drug development and commercialization costs.
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Advances in pharmacology and oncology research has resulted in rapid growth in the demand for high potency APIs. To meet this ever increasing demand, contract manufacturers are trying to strengthen HPAPI manufacturing capacities and also acquire necessary technological expertise. Although the HPAPI market currently accounts for a small percentage of total active pharmaceutical ingredient market, advances in oncology therapeutics research and strong drug pipeline comprising HPAPI is expected to fuel the global market growth. The global HPAPI market was valued at US$ 12,644.6 Mn in 2014 and is projected to reach US$ 25,118.7 Mn by 2023, expanding at a CAGR of 7.8% from 2015 to 2023.
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Various blockbuster drugs in oncology segment comprising HPAPIs are scheduled to loose patent protection in the near future. This would create profitable opportunities for generic drug manufacturers, and in turn for HPAPI contract manufacturing organizations. In spite of patent expiry of key blockbuster drugs, the market for branded HPAPIs would continue to lead, on the grounds of their high cost. Oncology segment accounts for more than 50% of the global HPAPI market (in 2015) owing to large number of branded drugs. This segment would continue to lead the market throughout the forecast period and is also expected to be the fastest growing HPAPI market segment by therapeutic area. Anticipated launch of antibody drug conjugates and monoclonal antibodies in the segment would propel market growth.
North America and Europe currently house majority of the HPAPI manufacturing organization and pharmaceutical drug manufacturing organization. Leading pharmaceutical companies with portfolio comprising HPAPIs were skeptical in outsourcing HPAPI production outside the country, especially in the Asian countries to avoid patent infringement. However with improving legal and regulatory policies, coupled with low production opportunities, HPAPI manufacturing in Asia Pacific would grow at a faster rate as compared to North America and Europe.
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Key players in the market include Alkermes plc, Cambrex Corporation, Dr. Reddy’s Laboratories, Lonza Group, Novasep, Sandoz International GmbH, Pfizer, Inc., Sigma-Aldrich Co. LLC., WuXi AppTec
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